NCT03641846

Low-intensity Shockwave Therapy (LiST) for the Treatment of Mild and Mild-to-moderate Vasculogenic Erectile Dysfunction

"Low-intensity Shockwave Therapy (LiST) for the Treatment of Mild and Mild-to-moderate Vasculogenic Erectile Dysfunction: a Randomized Placebo Controlled Two-parallel Arms Trial, Comparing 6 Sessions, With Daily Tadalafil 5mg vs Placebo"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, 2 parallel arms clinical trial. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 50 men with vasculogenic ED with primary objective to examine the efficacy of LiST using Aries2 device.

Conditions

• Erectile Dysfunction
• Low Intensity Shockwave Therapy

Interventions

Type	Name	Description
OTHER	DornierAries2 LiST device + 5 mg Tadalafil	All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks
OTHER	DornierAries2 LiST device + Placebo Pill	All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Placebo pills. Total treatment period = 4 weeks.

Timeline

• Start date: 2018-08-28
• Primary completion: 2021-01-15
• Completion: 2021-04-16
• First posted: 2018-08-22
• Last updated: 2022-05-05

Locations

1 site across 1 country: Greece